|Year : 2019 | Volume
| Issue : 4 | Page : 202-207
Blood glucose control and opportunities for clinical pharmacists in infectious diseases ward
Minoosh Shabani1, Maryam Rashedi2, Sareh Razzazzadeh3, Ali Saffaei4, Zahra Sahraei5
1 Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
2 Students' Research Committee, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3 Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4 Students' Research Committee; Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
5 Department of Clinical Pharmacy, School of Pharmacy; Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
|Date of Submission||27-Dec-2018|
|Date of Acceptance||02-Aug-2019|
|Date of Web Publication||27-Dec-2019|
Dr. Zahra Sahraei
Department of Clinical Pharmacy, School of Pharmacy; Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran
Source of Support: None, Conflict of Interest: None
Objective: Increased risk of infection following hyperglycemia has been reported in hospitalized patients. Sliding-scale insulin protocol is an out-of-date method; therefore, it is necessary to examine new approaches in this regard. This study aimed to evaluate the efficacy of sliding-scale protocol versus basal-bolus insulin protocol, which supervised by clinical pharmacists in an infectious disease ward. Methods: In this prospective randomized clinical trial, 90 hyperglycemic patients who hospitalized in Loghman Hakim Hospital Infectious Disease Ward (Tehran, Iran) were randomized into two groups: sliding-scale insulin protocol (the control group) and the basal-bolus protocol groups that were under supervision clinical pharmacists. Some demographic, laboratory, and clinical variables, as well as patient's blood glucose were measured four times daily. Findings: The results indicated significant improvement among the patients in the intervention group. General indicators including fever, blood glucose level, the duration of hospitalization, incidence of hypoglycemia, days to achieve normal blood glucose, and leukocyte count improved in intervention group. Conclusion: According to this study, basal-bolus insulin protocol, which supervised by clinical pharmacy service, showed better blood glucose control and infection remission compared to the sliding-scale protocol.
Keywords: Cellulitis, diabetes mellitus, hyperglycemia, pharmacy service, pneumonia
|How to cite this article:|
Shabani M, Rashedi M, Razzazzadeh S, Saffaei A, Sahraei Z. Blood glucose control and opportunities for clinical pharmacists in infectious diseases ward. J Res Pharm Pract 2019;8:202-7
|How to cite this URL:|
Shabani M, Rashedi M, Razzazzadeh S, Saffaei A, Sahraei Z. Blood glucose control and opportunities for clinical pharmacists in infectious diseases ward. J Res Pharm Pract [serial online] 2019 [cited 2020 Jan 29];8:202-7. Available from: http://www.jrpp.net/text.asp?2019/8/4/202/274151
| Introduction|| |
Diabetes mellitus is a significant cause of morbidity and mortality, which needs careful monitoring and control from diagnosis. Blood glucose level monitoring is one of the most important medical challenges, especially in the infectious diseases ward. High blood glucose level suppresses the immunity system. Hence, the risk of secondary infections can increase. This effect is more critical in patients with underlying infectious diseases or those that are undergoing surgical operations. Hence, effective blood glucose controlling is a crucial mission in an infectious disease ward. There are several strategies to control the blood glucose of patients who have been admitted to the hospital. The most common approach to treat hospitalized patients with diabetes mellitus is sliding-scale insulin therapy. In the sliding-scale method, premeal insulin dose adjusted based on the blood glucose level before the meal. Although sliding-scale insulin therapy is an inefficient and out-of-date method, as reported by several previous studies. However, it remains as the most used method due to its feasibility. This method is unable to decrease highly elevated glucose levels and may worsen the situation through hypoglycemia. This method does not consider the patient's diet, weight, previous insulin dose, and patient's sensitivity to insulin. Due to the problems mentioned above, most guidelines discouraged using sliding-scale insulin therapy. Hence, it is necessary to employ other strategies, such as bolus fixed doses of basal insulin. Some studies mentioned the critical role of clinical pharmacists in infectious diseases ward by effective blood glucose control., Hence, the implementation of a clinical pharmacist can help to better blood glucose control. This study aimed to evaluate the efficacy of sliding-scale protocol versus basal-bolus insulin protocol, which supervised by clinical pharmacists in an infectious diseases ward of a University Hospital in Tehran, Iran.
| Methods|| |
This study was a randomized clinical trial which conducted in Loghman Hakim Teaching Hospital affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran. The Ethics Committee of Shahid Beheshti University of Medical Sciences approved the protocol of this study with number IR.SBMU.PHNM.1395.606, and this trial registered in the Iranian Registry of Clinical Trials with number IRCT20130917014693N9. This study was done between April 2017 and September 2017. The sample size of this study was estimated by GPower software (Heinrich Heine Universität Düsseldorf, Germany). It showed a sample size of 90 would have >80% power to detect a statistically significant change by effect size = 0.6 by alpha = 0.05 (two-tailed). Ninety patients who hospitalized in the infectious diseases ward were enrolled in this study. Inclusion criteria of this study were as follow: (1) patients who hospitalized in infectious diseases ward due to three important infections which diagnosed by infectious diseases specialist (pneumonia, cellulitis, and diabetic foot infection); (2) had diabetes mellitus as comorbidity which diagnosed by endocrinologist specialist; (3) were more than 18 years old; and (4) were on subcutaneous insulin regimen. Patients with following criteria were excluded from the study: (1) pregnant patients; (2) surgical patients; (3) patients with end-stage renal disease (glomerular filtration rate <10 mL/min); (4) patients on intravenous insulin; (5) patients on total parental nutrition; and (6) patients who did not sign the patient informed consent form. The included patients randomized into two equal groups (n = 45) as control and intervention groups. The randomization was done through computer software (Sealed Envelope Ltd., London, UK). Patients in the control group received the sliding-scale insulin therapy. According to this protocol, a varying dose of regular insulin administered based on the blood glucose level before the meal (measured every 6 h). In the intervention group, the needed daily insulin dose for each patient calculated and then converted to one dose of long-acting insulin (neutral protamine Hagedorn + regular). These doses were given in the morning and evening. In both groups, none of the oral antidiabetic agents administered. Patients received basal-bolus insulin based on the American Diabetes Association (ADA) guideline, and this intervention was done under the supervision of a clinical pharmacist.
Then, the patients were visited daily by a physician and a clinical pharmacist. Demographic variables, laboratory variables, and clinical variables including age, sex, weight, type of infection, glycosylated hemoglobin (HbA1c), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), platelet count, white blood cell count (WBC), hemoglobin, serum creatinine, fever grade, level of consciousness, and nutritional status were measured. Furthermore, the blood glucose level was measured every 6 h. Specific indicators for each infection were recorded. The severity of pneumonia was evaluated by heart rate, blood pressure, respiratory rate, oxygen saturation, and CURB-65 pneumonia severity score (confusion, blood urea > 42,8 mg/dl, respiratory rate > 30/min, blood pressure < 90/60 mm Hg, age > 65 years). The severity of diabetic foot infections was determined by perfusion, extent, depth, infection, and sensation. The wound area among both diabetic foot infection and cellulitis patients were monitored daily by the wound mapping factor. Parameters related to the control of underlying infectious diseases such as fever, duration of hospitalization, and rate of mortality were also recorded. All variables measured at baseline and the end of the study. Data were analyzed using the Statistical Package for the Social Sciences, SPSS software (IBM Corp., Released 2013. IBM SPSS Statistics for Windows, Version 22.0, Armonk, NY, USA: IBM Corp.). The statistical tests employed for data analysis were Independent t-test, Chi-square test, or Fisher's exact test where appropriate. P < 0.05 considered as statistically significant level.
| Results|| |
A total of 90 patients with each of community-acquired pneumonia, cellulitis, or diabetic foot infections were evaluated between April 2017 and September 2017. The Consolidated Standards of Reporting Trials diagram of the current study is shown in [Figure 1]. Evaluation of baseline parameters (age, sex, HbA1c, serum level of creatinine, hemoglobin, platelet count, ESR, CRP, level of consciousness, fever grade, WBC, and nutritional status) demonstrated no significant difference between two groups. Evaluation of outcomes related to controlling blood glucose level revealed a statistically significant between the two groups. In the intervention group, all blood glucose levels were in the accepted range [Table 1]. Evaluation of outcomes related to the time needed to achieve normal blood glucose levels also demonstrated that this time was shorter in the intervention group [Table 2].
|Figure 1: The Consolidated Standards of Reporting Trials (CONSORT) diagram of the current study|
Click here to view
The results of secondary outcomes evaluation are shown in [Table 3]. All secondary outcomes were improved in the intervention group.
Among pneumonia patients, oxygenation lasted 10.15 ± 5.01 days to improve for control and 5.64 ± 1.69 days to improve for the intervention group (P = 0.01). Tachypnea lasted 9.17 ± 4.83 days for the control group and 5.44 ± 2.01 days for the intervention group to resolve (P = 0.06). The secondary outcomes among diabetic foot infection patients are shown in [Table 4].
Among cellulitis patients, wound mapping significantly improved in the intervention group. 44.00% ± 12.42% wound mapping reduction in control group and 55.33% ± 15.97% in intervention group (P = 0.039).
| Discussion|| |
The aim of this study was to evaluate the efficacy of sliding-scale protocol versus basal-bolus insulin protocol, which supervised by clinical pharmacists in the infectious diseases ward. The standards of this study and also the overall methods and instructions are based on ADA guidelines 2015. As mentioned, blood glucose and infections have a reciprocal relationship as the worsening of one may worsen the other. Since 2009, the ADA guideline has suggested insulin therapy for the critically patients with hyperglycemia or blood plasma glucose above 180 mg/dl. ADA and American Association of Clinical Endocrinologists guidelines also suggested the normal level for blood glucose as 140–180 mg/dl.
The results of the current study generally demonstrate that better control on blood glucose levels was seen among the basal-bolus insulin group. In each group, infection resolution improved along with better glucose control. However, results related to the percentage of patients with normal blood glucose and diabetic foot infection did not show a statistically significant improvement compared to the control group. This pattern was probably due to the severity of the disease and higher levels of HbA1c at the baseline. Brenner demonstrated that intensive blood glucose control in diabetic patients is essential to improve diabetic foot infection. Kitabchi and Nyenwe proved the beneficial effect of discontinuing sliding-scale insulin protocol in various hospital wards. However, more studies are needed to support this claim. Similar the current study design, Umpierrez et al. evaluated the efficacy of sliding-scale insulin therapy versus basal-bolus insulin. In that study, one group received a sliding-scale insulin protocol and the other one received a basal-bolus insulin protocol. This study leads to better blood glucose control among the basal-bolus insulin group, which confirms the current study. The main limitation of that study was the lack of accurate randomization and heterogeneous baseline parameters.
Another prospective study in 2014 by Zaman Huri et al. concluded there are lower levels of fasting blood glucose and lower average daily glucose level among the basal-bolus insulin group. Similar results were observed in the current study, which showed more normal glucose levels among the intervention group compared to the control group. In the current study, hypoglycemia incidence in the intervention group was 25%, which is notably decreased compared to the control group (45%). Therefore, a basal-bolus protocol is highly capable of decreasing hypoglycemia incidence among inpatients. Arinzon et al. and Jan et al. in 2009 proved that hypoglycemia may happen as a reason for underlying infection and effectively increases the mortality rate., The results show that the average hospitalization period decreased although not significantly, probably due to the limited course of the study. The average hospitalization period in the infectious diseases ward is 4–10 days, which is relatively short. Therefore, a long-term evaluation of the effect of blood glucose controlling on hospitalization duration was not possible. Van den Berghe et al. studied 1200 ICU patients in 2006 and demonstrated that basal-bolus can decreases (3 days) hospitalization period, compared with sliding-scale protocol., Fever resolution was observed 2 days earlier for the intervention group compared to the control group, although not significantly due to a limited course of study and a short period of hospitalization. Leukocytosis diminished 1 day earlier for the intervention group compared to the control group, although not to a significant degree due to various causes such as differences in disease severity, limited course of hospitalization, and the incompetency of the protocol for controlling WBC count. Previous studies showed that intensive blood glucose control helps decreases the fluctuations in the activity of the immune system and regulates the release of inflammatory mediators. This study shows the effect of controlled blood glucose on mortality reduction. However, since the sample size is comparably small, more investigations are recommended. Marston et al. demonstrated that better control of blood glucose results in significant infection remission among patients. This effect was also observed through the current study. Among diabetic foot infection patients, evaluation of wound mapping and wound secretions is crucial to estimate wound healing. Both mentioned parameters decreased significantly among the intervention group with P = 0.046 for wound mapping reduction and P = 0.007 for wound secretion reduction. The average wound debridement in the intervention group was 0.79, whereas it was 2.00 for the control group, showing a sensible reduction in the intervention group. These observations also demonstrate the efficacy of our protocol on the patient's clinical condition. Among infectious cellulitis patients, the average reduction in wound mapping was higher significantly in the intervention group. On the period of oxygenation among pneumonia patients, it lasted up to 10 days for the control group, whereas only 5 days for the intervention group. Castellanos et al. studied in 2012 on elderly diabetic patients with pneumonia, revealed that even a slight elevation in average daily blood glucose, especially fasting blood glucose between 101 and 125 mg/dL is capable of increasing pneumonia complications. A similar study also conducted by a team of clinical pharmacists on the role of clinical pharmacists in educating patients about the proper method of insulin injection and the importance of blood glucose control, especially in the course of infection treatment. This study had some limitations, such as lack of randomization and control group. Both mentioned limitations have been resolved in the current study. Notably, the prominent finding of this study was the significant effect of blood glucose control on infection improvement. A multidisciplinary team, including a clinical pharmacist, may significantly affect the course of treatment to reduce mortality and morbidity and improve the quality of life in diabetic patients. A notable finding through the course of study was the impressive role of the clinical pharmacist as a member of health-care providers to provide blood glucose control protocol as an effective tool to achieve various improvements in the course of treatment.
| Authors' Contribution|| |
Minoosh Shabani and Zahra Sahraei proposed the idea and supervised the whole project. Maryam Rashedi and Sareh Razzazzadeh involved in the clinical aspects and data gathering. Ali Saffaei analyzed the data and commented on the presentation of the results. All authors involved in the manuscript preparation and finally all of them revised and approved the final version of manuscript.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Siavash M, Tabbakhian M, Sabzghabaee AM, Razavi N. Severity of gastrointestinal side effects of metformin tablet compared to metformin capsule in type 2 diabetes mellitus patients. J Res Pharm Pract 2017;6:73-6.
] [Full text]
Pearson-Stuttard J, Blundell S, Harris T, Cook DG, Critchley J. Diabetes and infection: Assessing the association with glycaemic control in population-based studies. Lancet Diabetes Endocrinol 2016;4:148-58.
Kogan A, Ram E, Levin S, Fisman EZ, Tenenbaum A, Raanani E, et al.
Impact of type 2 diabetes mellitus on short – And long-term mortality after coronary artery bypass surgery. Cardiovasc Diabetol 2018;17:151.
Colunga-Lozano LE, Gonzalez Torres FJ, Delgado-Figueroa N, Gonzalez-Padilla DA, Hernandez AV, Roman Y, et al.
Sliding scale insulin for non-critically ill hospitalised adults with diabetes mellitus. Cochrane Database Syst Rev 2018;11:CD011296.
Woods J, Nadelson M. Sliding-scale insulin use in long-term care: An updated perspective. Consult Pharm 2017;32:105-8.
Hirsch IB. Sliding scale insulin – Time to stop sliding. JAMA 2009;301:213-4.
Farsaei S, Karimzadeh I, Elyasi S, Hatamkhani S, Khalili H. Glycemic control in the infectious diseases ward; role of clinical pharmacist interventions. J Infect Dev Ctries 2014;8:480-9.
Warrington L, Ayers P, Baldwin AM, Wallace V, Riche KD, Saulters R, et al.
Implementation of a pharmacist-led, multidisciplinary diabetes management team. Am J Health Syst Pharm 2012;69:1240-5.
American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes 2015;33:97-111.
Lipshutz AK, Gropper MA. Perioperative glycemic control: An evidence-based review. Anesthesiology 2009;110:408-21.
Jellinger PS, Dickey RA, Ganda OP, Mehta AE, Nguyen TT, Rodbard HW, et al.
AACE medical guidelines for clinical practice for the diagnosis and treatment of dyslipidemia and prevention of atherogenesis. Endocr Pract 2000;6:162-213.
Brenner ZR. Management of hyperglycemic emergencies. AACN Clin Issues 2006;17:56-65.
Kitabchi AE, Nyenwe E. Sliding-scale insulin: More evidence needed before final exit? Diabetes Care 2007;30:2409-10.
Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, et al.
Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care 2007;30:2181-6.
Zaman Huri H, Permalu V, Vethakkan SR. Sliding-scale versus basal-bolus insulin in the management of severe or acute hyperglycemia in type 2 diabetes patients: A retrospective study. PLoS One 2014;9:e106505.
Arinzon Z, Fidelman Z, Berner YN, Adunsky A. Infection-related hypoglycemia in institutionalized demented patients: A comparative study of diabetic and nondiabetic patients. Arch Gerontol Geriatr 2007;45:191-200.
Jan IS, Tsai TH, Chen JM, Jerng JS, Hsu HF, Hung PL, et al.
Hypoglycemia associated with bacteremic pneumococcal infections. Int J Infect Dis 2009;13:570-6.
Van den Berghe G, Wilmer A, Milants I, Wouters PJ, Bouckaert B, Bruyninckx F, et al.
Intensive insulin therapy in mixed medical/surgical intensive care units: Benefit versus harm. Diabetes 2006;55:3151-9.
Van den Berghe G, Wouters PJ, Bouillon R, Weekers F, Verwaest C, Schetz M, et al.
Outcome benefit of intensive insulin therapy in the critically ill: Insulin dose versus glycemic control. Crit Care Med 2003;31:359-66.
Butler SO, Btaiche IF, Alaniz C. Relationship between hyperglycemia and infection in critically ill patients. Pharmacotherapy 2005;25:963-76.
Marston WA; Dermagraft Diabetic Foot Ulcer Study Group. Risk factors associated with healing chronic diabetic foot ulcers: The importance of hyperglycemia. Ostomy Wound Manage 2006;52:26-8, 30, 32.
Castellanos MR, Szerszen A, Saifan C, Zigelboym I, Khoueiry G, Abi Rafeh N, et al.
Fasting hyperglSycemia upon hospital admission is associated with higher pneumonia complication rates among the elderly. Int Arch Med 2010;3:16.
[Table 1], [Table 2], [Table 3], [Table 4]